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QC Software and Application specialist - Job Opportunity at Lonza

Geleen, Netherlands
Full-time
Mid-level
Posted: June 3, 2025
On-site
EUR 45,000 - 60,000 annually based on Netherlands pharmaceutical industry standards for mid-level QC specialists with LIMS expertise and 2+ years experience

Benefits

Comprehensive career ownership program allowing employees to drive their professional development trajectory
Global exposure and collaboration opportunities across five continents within the life sciences sector
Access to cutting-edge scientific solutions and innovative project work
Equal opportunity employment with strong diversity and inclusion commitments
Reasonable accommodation support for individuals with disabilities
Meaningful work contributing to positive impact on millions of lives globally
Ethical workplace culture with environmental protection and sustainability focus

Key Responsibilities

Lead strategic LIMS implementation projects including comprehensive master data architecture, system modifications, and enterprise-wide updates to support organizational scalability
Execute critical data validation and spreadsheet maintenance protocols ensuring regulatory compliance and supporting high-stakes analytical reporting for pharmaceutical operations
Drive technical documentation excellence through creation of SOPs, validation protocols, and compliance reports that directly impact regulatory submissions and audit outcomes
Manage enterprise software and system administration responsibilities ensuring 24/7 operational continuity for quality control operations
Facilitate cross-functional collaboration with regulatory affairs, manufacturing, and quality assurance teams to maintain GMP compliance and exceed internal quality benchmarks
Execute sophisticated commercial trending analysis using statistical methods to identify process deviations, quality patterns, and strategic improvement opportunities
Champion continuous improvement initiatives that deliver measurable efficiency gains and cost optimization across the entire QC department
Provide technical mentorship and professional development support to junior team members, building organizational capability and knowledge transfer
Coordinate comprehensive compliance oversight within QC operations, ensuring adherence to FDA, EMA, and other international regulatory requirements
Lead transformational quality improvement projects affecting enterprise-wide QC operations, implementing advanced processes, technologies, and methodologies
Manage complex deviation investigations and CAPA implementation processes, conducting root cause analysis and implementing sustainable corrective actions
Orchestrate critical sample and material shipment logistics ensuring chain of custody, temperature control, and regulatory compliance for global operations
Execute operational excellence initiatives including facility management, inventory optimization, equipment qualification, and staff training coordination

Requirements

Education

Bachelor's degree in a relevant scientific field (e.g., chemistry, biology, or related subject area)

Experience

Minimum of 2 years of experience in a QC or related role within the pharmaceutical, biotechnology, or similar industry

Required Skills

Proficiency in LIMS software and experience with master data creation and modification Strong analytical skills with the ability to collaborate effectively with cross-functional teams Diligent with a dedication to maintaining high-quality standards Experience in technical writing and documentation
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Industry Trends

The pharmaceutical and biotechnology industry is experiencing unprecedented digital transformation with LIMS and laboratory informatics becoming critical competitive differentiators. Companies are investing heavily in integrated laboratory data management systems to support accelerated drug development timelines and regulatory compliance requirements. This trend is driving significant demand for QC professionals who can bridge the gap between traditional quality control practices and modern digital laboratory technologies. Regulatory agencies worldwide are increasing their focus on data integrity and electronic records management, creating a surge in demand for QC specialists with strong technical documentation and compliance expertise. The FDA's emphasis on computerized system validation and the EU's Annex 11 requirements are reshaping how pharmaceutical companies approach quality control operations. The global pharmaceutical market's shift toward personalized medicine and complex biologics is creating new quality control challenges that require sophisticated analytical methods and cross-functional collaboration skills. QC professionals who can work effectively across multiple disciplines and adapt to emerging technologies are becoming increasingly valuable in the current market.

Role Significance

Typically manages or influences 3-8 team members including junior QC analysts and laboratory technicians, while collaborating across multiple cross-functional teams spanning regulatory affairs, manufacturing, IT, and quality assurance departments
This role represents a mid-level specialist position with significant technical responsibility and leadership components. The combination of project management duties, mentorship responsibilities, and enterprise-wide impact initiatives indicates a role that serves as a bridge between junior QC staff and senior management, with clear pathway to senior specialist or supervisory positions.

Key Projects

Enterprise LIMS implementation and optimization projects affecting multiple laboratory sites Regulatory compliance audits and remediation initiatives Commercial product trending analysis and quality risk assessments Cross-functional process improvement initiatives with measurable ROI impact Deviation investigation and CAPA implementation projects Laboratory digitization and automation integration projects

Success Factors

Technical expertise in laboratory informatics and data management systems combined with deep understanding of pharmaceutical manufacturing and quality control processes Strong project management capabilities with ability to coordinate complex initiatives across multiple departments while maintaining strict regulatory compliance standards Exceptional communication and documentation skills essential for creating technical procedures, training materials, and regulatory submissions that can withstand audit scrutiny Analytical thinking and problem-solving abilities crucial for conducting root cause analysis, identifying process improvements, and implementing sustainable solutions Leadership and mentoring capabilities necessary for developing junior staff and driving organizational change initiatives Adaptability and continuous learning mindset required to stay current with evolving regulatory requirements and emerging laboratory technologies

Market Demand

High demand driven by pharmaceutical industry growth, regulatory compliance requirements, and digital transformation initiatives

Important Skills

Critical Skills

LIMS proficiency is absolutely essential as this technology forms the backbone of modern pharmaceutical quality control operations, enabling data integrity, regulatory compliance, and operational efficiency that directly impacts product release and patient safety Technical writing and documentation skills are mission-critical in the highly regulated pharmaceutical environment where SOPs, protocols, and reports must meet stringent regulatory standards and serve as legal documents during inspections and audits Cross-functional collaboration abilities are vital for success as QC operations intersect with manufacturing, regulatory affairs, R&D, and commercial teams, requiring effective communication and relationship management across diverse technical disciplines Analytical and problem-solving skills are fundamental for conducting deviation investigations, implementing CAPAs, and identifying process improvements that ensure product quality and regulatory compliance while optimizing operational efficiency

Beneficial Skills

Project management certification (PMP) would enhance ability to lead complex LIMS implementations and cross-functional improvement initiatives Statistical analysis software proficiency (SAS, R, Minitab) would strengthen commercial trending analysis and data interpretation capabilities Regulatory affairs knowledge (ICH guidelines, FDA/EMA regulations) would provide valuable context for compliance coordination responsibilities Change management skills would support leadership of organizational transformation initiatives and technology implementations Six Sigma or Lean methodology training would enhance continuous improvement project effectiveness and measurable impact delivery

Unique Aspects

Combination of technical LIMS expertise with broad QC operational responsibilities creates a unique hybrid role that bridges IT and laboratory functions
Direct involvement in commercial trending analysis provides exposure to business intelligence and market analytics beyond traditional QC roles
Mentorship and leadership responsibilities at mid-level position indicates accelerated career development opportunities
Global company context with local facility focus offers both international exposure and community integration
Integration of compliance coordination with technical project management creates comprehensive regulatory and operational experience

Career Growth

Typically 2-4 years to advance to senior specialist level, 4-6 years to reach supervisory or management positions with continued professional development and successful project delivery

Potential Next Roles

Senior QC Specialist or Principal QC Scientist with expanded technical leadership responsibilities QC Supervisor or Manager overseeing multiple laboratory functions and staff Regulatory Affairs Specialist focusing on quality compliance and submissions Laboratory Informatics Manager specializing in LIMS and digital laboratory systems Quality Assurance Manager with broader organizational oversight responsibilities

Company Overview

Lonza

Lonza is a globally recognized leader in pharmaceutical and biotechnology manufacturing with over 120 years of industry experience and operations spanning five continents. The company serves as a critical partner to pharmaceutical companies worldwide, providing contract development and manufacturing services, specialty chemicals, and biotechnology solutions that enable drug development and production.

Lonza holds a dominant position in the contract development and manufacturing organization (CDMO) market, particularly in biologics manufacturing and pharmaceutical intermediates. The company's extensive global footprint and regulatory expertise make it a preferred partner for both established pharmaceutical companies and emerging biotechnology firms.
The Geleen facility represents Lonza's significant European operations hub, strategically positioned to serve the robust pharmaceutical and chemical industries in the Netherlands, Germany, and broader European market. This location provides access to highly skilled scientific talent and proximity to major pharmaceutical company headquarters and research centers.
Lonza emphasizes scientific innovation and collaborative problem-solving while maintaining rigorous quality and safety standards. The company culture promotes employee ownership of career development and encourages creative thinking in addressing complex scientific challenges, balanced with strong ethical principles and environmental responsibility.
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